Psychological and Social Problems in Patients With Heart Failure

Psychosocial Syndemics and Multimorbidity in Hospitalized Patients With Heart Failure

Sponsors

Lead Sponsor: Washington University School of Medicine

Source Washington University School of Medicine
Brief Summary

Heart failure (HF) is a common and debilitating chronic disease with a poor prognosis. Many patients with HFhave psychiatric problems such as depression and other medical disorders such as lung or kidney disease.This study will examine the effects that these psychiatric and medical disorders have on HF outcomes.

Detailed Description

Approximately 6.2 million Americans have heart failure (HF) and the prevalence is increasing rapidly. HF is a common cause of hospitalization and mortality in older adults, and the cost of hospital care for HF is skyrocketing. One reason why HF is so burdensome and costly is that it is often complicated by cardiovascular and noncardiovascular comorbidities, especially in older patients. Psychiatric and medical disorders that are risk factors for incident HF persist after HF has developed, and additional comorbidities accumulate as patients with HF grow older. Thus, HF is embedded within a larger pattern of multimorbidity. Unfortunately, most trials of HF therapies as well as many other studies of HF have excluded patients with complex psychiatric and medical comorbidities or severe cognitive impairment. This has left large gaps in research on the care of older adults with HF. In addition, research on socioeconomic risk factors and health disparities has not been integrated with research on multimorbidity in HF. Heart failure is only one of multiple challenges facing patients with multimorbidity, stressful socioeconomic circumstances, and psychosocial problems, but the fragmentation of research on HF has left us with little understanding of patients with complex psychosocial problems. The purpose of this study is to identify combinations of comorbidities and health disparities may affect HF outcomes and require different mixtures of medical, psychological, and social services to address. It will encompass both psychiatric and medical comorbidities but will emphasize the role of psychiatric comorbidities. Syndemics theory is a useful framework for studying this type of psychosocial and medical complexity. Syndemics, also known as synergistic epidemics, occur when there are adverse interactions between prevalent disorders that concentrate in populations that are vulnerable due to adverse socioeconomic or environmental conditions. The syndemics framework has yielded important insights into a number of other disorders, but it has not been used to study the complex psychosocial problems of patients with HF. To our knowledge, this will be the first study of the syndemics of psychiatric and medical comorbidities in heart failure. The multimorbidity framework is an alternative approach for investigating the effects of multiple comorbidities on health outcomes. The specific aims of the study are: 1) to determine the coprevalence of major psychiatric and medical comorbidities in hospitalized patients with HF (n=535); 2) to determine whether coprevalent comorbidities have synergistic effects on 30-day all-cause readmission and mortality risks, heart failure self-care, and health-related quality of life; 3) to identify vulnerable subpopulations of hospitalized patients with HF who have higher coprevalences of syndemic comorbidities compared to less vulnerable subpopulations; 4) to determine the extent to which syndemic comorbidities explain adverse HF outcomes (30-day readmissions and mortality, poor self-care, and poor health-related quality of life) in vulnerable subgroups of hospitalized patients with HF; and 5) to determine the effects of multimorbidity on readmissions, mortality risk, self-care, and quality of life.

Overall Status Not yet recruiting
Start Date January 4, 2021
Completion Date April 30, 2024
Primary Completion Date April 30, 2024
Study Type Observational
Primary Outcome
Measure Time Frame
Hospital readmissions 2 years or less, depending upon available follow-up time
Secondary Outcome
Measure Time Frame
HF Self-Care Baseline
Global health Baseline
Medication management Baseline
Activities of daily living Baseline
Enrollment 535
Condition
Intervention

Intervention Type: Other

Intervention Name: Hospitalization

Description: Hospitalization for any reason

Arm Group Label: Patients with Heart Failure

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria: - Discharged from an inpatient hospitalization within the past month, AND - had a clinical diagnosis of HF at admission to or discharge from the hospital, AND - met the European Society of HF diagnostic criteria during the hospital stay. Exclusion Criteria: - Attending physician withholds permission to recruit the patient, OR - patient refuses to participate, OR - agent with health care power of attorney refuses to allow the patient to participate, OR - isolated right HF (cor pulmonale), OR - reversible HF due to valve disease with impending surgical correction.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Kenneth E Freedland, PhD Principal Investigator Washington University School of Medicine
Overall Contact

Last Name: Kenneth E Freedland, PhD

Phone: 314-286-1311

Email: [email protected]

Location
Facility: Contact: Investigator: Washington University School of Medicine Behavioral Medicine Center Jessica Winker, MPH 314-286-1313 [email protected] Kenneth E Freedland, Ph.D. Principal Investigator
Location Countries

United States

Verification Date

November 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Washington University School of Medicine

Investigator Full Name: Kenneth Freedland

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Arm Group

Label: Patients with Heart Failure

Description: Patients with heart failure who were discharged within the past month after hospitalization for any reason.

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov